Quality of life in rectal cancer patients with or without oxaliplatin in the randomised CAO/ARO/AIO-04 phase 3 trial

Research output: Contribution to journalResearch articleContributedpeer-review

Contributors

  • German Rectal Cancer Study Group - (Author)
  • Department of Medical Biology
  • University Cancer Centre Dresden
  • Department of Internal Medicine I
  • University Hospital of Würzburg
  • University Hospital Frankfurt
  • State Vocational Colleges at the University Hospital Erlangen
  • University Medical Center Göttingen
  • Clinics Maria Hilf GmbH
  • Asklepios Clinic Altona
  • SRH University of Applied Sciences Heidelberg
  • Klinikum Esslingen
  • University Hospital Carl Gustav Carus Dresden
  • University Medical Center Freiburg
  • Friedrich-Alexander University Erlangen-Nürnberg

Abstract

BACKGROUND: The CAO/ARO/AIO trial has shown that oxaliplatin added to preoperative chemoradiotherapy and postoperative chemotherapy significantly improved disease-free survival in locally advanced rectal cancer (LARC). Here, we present a post-hoc analysis of quality of life (QoL) in disease-free patients.

PATIENTS AND METHODS: Between 2006 and 2010, 1236 patients with LARC were randomly assigned either to preoperative chemoradiotherapy followed by total mesorectal excision and postoperative chemotherapy (N = 623) or combined with oxaliplatin (N = 613). QoL questionnaires (EORTC QLQ-C30, colorectal module CR38) were completed at baseline, after postoperative chemotherapy and during follow-up. Analysis was performed according intent-to-treat.

RESULTS: Available questionnaires (baseline) were 82% (N = 512) in the control and 84% (N = 513) in the investigational group. Response rates were 49% (533 of 1086) at 1 year and 43% (403 of 928) at 3 years. Global health status (GHS) for disease-free patients was stable in both groups (range 0-100). At baseline: standard arm 62.0 (mean, SD 21.6; N = 491) versus oxaliplatin arm 63.2 (mean, SD 22; N = 503); at 3 years: 69.4 (SD 19.3; N = 187) versus 65.4 (SD 22.2; N = 202). After treatment and at 3 years, no significant differences (≥10 points) between groups were found in QoL subscales. Disease-free patients experiencing neurotoxic side-effects (grade 1-4) showed reduced GHS at 3 years versus patients without neurotoxicity (mean 59.2 versus 69.3; P < 0.001), while grade 3-4 rate was low.

CONCLUSION: The addition of oxaliplatin was not associated with worse overall QoL. This information is of interest to patients in many ongoing rectal cancer trials.

TRIAL REGISTRATION INFORMATION: NCT00349076.

Details

Original languageEnglish
Pages (from-to)281-290
Number of pages10
JournalEuropean journal of cancer
Volume144
Publication statusPublished - Feb 2021
Peer-reviewedYes

External IDs

Scopus 85098184174
ORCID /0000-0002-9321-9911/work/142251958

Keywords

Sustainable Development Goals

Keywords

  • Adenocarcinoma, Mucinous/pathology, Aged, Antineoplastic Combined Chemotherapy Protocols/therapeutic use, Carcinoma, Signet Ring Cell/pathology, Chemoradiotherapy/mortality, Chemotherapy, Adjuvant/mortality, Female, Fluorouracil/administration & dosage, Follow-Up Studies, Humans, Male, Middle Aged, Neoadjuvant Therapy/mortality, Oxaliplatin/administration & dosage, Prognosis, Quality of Life, Rectal Neoplasms/pathology, Survival Rate